CancerMAW Phase 2NCT02018640
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
An observational study of Cancer and Tobacco Use, run by Mayo Clinic at 1 site in United States.
Trial summary
Use of tobacco is very high among Alaska Native pregnant women. The investigators are conducting a three phase study. The first study is nearly completed and involved measuring biomarkers of tobacco exposure in mothers and infants. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Tobacco Use, Pregnancy
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Alaska Native women and their confidants
Who may be able to join
- To be eligible the woman must:
- be Alaska Native
- be aged 18 years of age or older
- provide written informed consent
- have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks gestation)
- have used any tobacco product at least once in the past 7 days (cigarettes or both cigarettes/ST)
Show all 10Show fewer
- To be eligible the confidant (he/she) must:
- be referred by the woman participant
- be aged 18 years of age or older
- provide written informed consent
Who cannot join
- 1. does not provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99577
About this study
Use of tobacco is very high among Alaska Native pregnant women. The investigators are conducting a three phase study. The first study is nearly completed and involved measuring biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a qualitative study to translate the biomarker findings to an intervention.
Read the detailed description
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on our successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. We propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 we utilized a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, we will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with women who use tobacco and a confidant (partner/friend/relative) they have identified to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance our understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
- Conditions
- Cancer, Tobacco Use, Pregnancy
- Keywords
- cancer, tobacco use, pregnancy
- Medical subject headings
- Neoplasms, Tobacco Use
What is being measured
The primary outcome is the main question the study is designed to answer.
receptivity to cancer risk messages
interview of participant reactions to biomarker findings
Measured: baseline
Secondary outcomes (1)
confidant perceptions of cancer risk information
interview of family members, friends, relatives
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, University of California, San Francisco, University of Minnesota, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018640
- Sponsor's protocol ID
- 11-001144 Phase 2
- Other IDs
- U54CA153605
- Acronym
- MAW Phase 2
- Status last verified
- Dec 2017
- First submitted
- 17 Dec 2013
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
- ClinicalTrials.gov ID
- NCT02018640
- Acronym / sponsor ID
- MAW Phase 2 / 11-001144 Phase 2
- Conditions
- Cancer, Tobacco Use, Pregnancy
- Keywords
- cancer, tobacco use, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, University of California, San Francisco, University of Minnesota, National Cancer Institute (NCI)
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of tobacco is very high among Alaska Native pregnant women. The investigators are conducting a three phase study. The first study is nearly completed and involved measuring biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a qualitative study to translate the biomarker findings to an intervention.
Detailed description
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on our successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. We propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 we utilized a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, we will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with women who use tobacco and a confidant (partner/friend/relative) they have identified to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance our understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Alaska Native women and their confidants
Key inclusion criteria (10 listed)
- be Alaska Native
- be aged 18 years of age or older
- provide written informed consent
- have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks gestation)
- have used any tobacco product at least once in the past 7 days (cigarettes or both cigarettes/ST)
Key exclusion criteria (1 listed)
- 1. does not provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
receptivity to cancer risk messages
Time frame: baseline
interview of participant reactions to biomarker findings
1 secondary outcome
confidant perceptions of cancer risk information
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Tobacco Use, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
receptivity to cancer risk messages (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.